BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY SCW DRIVER SHFT, CANNULTD

    MDR report key: 6247553 · Received January 12, 2017

    Report

    Report Number
    1526439-2017-10030
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CANNULATED POLYAXIAL SCREWDRIVER SHAFT (PRODUCT CODE: 2867-20-000, LOT NUMBER: UI0912) WAS RETURNED TO THE CUSTOMER QUALITY UNIT (CQU) ON JANUARY 31ST, 2017. THE DRIVER SHAFT FEATURED A SECTION OF ITS THREAD CHIPPED OFF TOWARDS THE DISTAL END OF THE INSTRUMENT. THIS MISSING SECTION COVERS APPROXIMATELY ONE EIGHTH OF A ROTATION AROUND THE DRIVER SHAFT. IT IS LOCATED APPROXIMATELY ONE QUARTER OF A ROTATION FROM THE START OF THE THREAD. THE SHAFT MAY HAVE BEEN ACCIDENTALLY CROSS-THREADED UPON INSERTION INTO THE SCREW. THE DAMAGE OCCURRED AS PRESSURE ON THE THREAD FROM AN ASSOCIATED SCREW¿S TULIP HEAD BUILT UP TO THE POINT THAT THE THREAD FRACTURED AND SPLIT OFF FROM THE DRIVER. THERE WERE ALSO SOME SIGNS OF GENERAL DAMAGE TO THE THREAD. THE VERY START OF THE THREAD IS WARPED AND THERE IS ALSO EVIDENCE OF DAMAGE TO THE SECTION OF THREAD IMMEDIATELY BELOW THE START OF THE THREAD. THE DAMAGE IS LIMITED TO THE BENT START OF THE THREAD AND THE ROUGH STRIP OF THE THREAD IMMEDIATELY BELOW IT. NO MATERIAL APPEARS TO BE MISSING FROM THE THREAD, BUT IT DOES APPEAR ROUGH, AS IF THE THREAD WAS RUBBING AGAINST SOMETHING WITH ENOUGH FORCE TO DAMAGE THE THREAD. THIS REINFORCES THAT THE DRIVER WAS CROSS THREADED WHEN IT WAS INSERTED INTO AN ASSOCIATED TULIP HEAD. THE DHR REVIEW IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF A SECTION OF THE DRIVER SHAFT THREAD BREAKING OFF CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE INADVERTENTLY CROSS THREADING THE DRIVER SHAFT TIP INTO AN ASSOCIATED TULIP HEAD DURING INSERTION AND SUBSEQUENT TIGHTENING, LEADING TO THE DRIVER SHAFT THREAD BREAKING. AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTIONS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTIONS REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE THREADS ON THE HEAD OF THE SCREW DRIVER CHIPPED. HOWEVER, NO FRAGMENTS FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29295 POLY SCW DRIVER SHFT, CANNULTD DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE UI0912

    Patients

    Seq Age Sex Outcome Treatment
    1